FDA recall D-1216-2015

Hospira Inc. · Class I · drug

Product

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Reason for recall

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Distribution

U.S. Nationwide including Guam.

Key facts

Status: Terminated
Initiation date: 2015-04-23
Report date: 2015-07-15
Termination date: 2016-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1216-2015